Performance Study of the SOLO 2.0 Insulin Pump

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The Purpose of the study is to to evaluate the performance of the SOLO (version 2.0) micropump insulin delivery system, in Type 1 diabetic patients who use insulin pumps for their treatment.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a multi center, one arm, open label and prospective study to assess the safety and quality of the SOLO 2.0 MicroPump Insulin Delivery System, following changes that were done to the SOLO previous version which was validated in 54 subjects.

SOLO 2.0 has the same intended use and core technology as previous SOLO with addition of safety measures, GUI changes and design changes for manufacturability.

The study will include a 30 days treatment period with the Solo MicroPump with no special care required for maintaining glycemic control and with an optional extension period of up to three month in Israel and up to six month in Austria.

The study includes 3 scheduled treatment and one follow up phone call one week after termination of the study. In case of participating the extension period, additional visits will consist once a month.

The study includes 3 scheduled treatment visits and one scheduled telephone call

Visit 1 includes eligibility, baseline evaluation and training in handling of the SOLO System. If no additional practice is required patients will be enrolled. Visit 2 will commence and Solo pump will be filled with insulin. If additional practice is required subject will be sent home for an additional training period of a few days practice using saline and then return for visit 2.

Treatment visits will take place at 3, 10 and 30 days after the enrolment. Additional visits will take place at 60, 90, 120 and 150 days depending on the extension period.

Medical assessment includes DTSQ information, Subject Diary, urine \& blood sampling, physical examination, the SOLO Performance Questionnaire, R\&D Questionnaire and Complaint Report Forms.Subjects will be asked to record blood glucose measurements, daily activities and carbohydrate consumptions between visits.

Seven days after termination of study treatment a telephone contact with the study subject will take place for the purpose of adverse event reporting and the completion of DTSQ questionnaire.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 1 Diabetes

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Insulin Pump Glycemic Control Type 1 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SOLO insulin pump

Use of the SOLO insulin pump for treatment of type 1 diabetes.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age range:
* 16 to 65 years (Graz)
* 18 to 65 years (Israel)
* Diabetic insulin pump user with diagnosis duration of more than 6 months.
* Subjects who are using Humalog®, NovoRapid®/NovoLog or Apidra® 100U/ml in- - Measures glucose at least four times per day.
* No more than one severe hypoglycemic or ketoacidosis episode within one year
* Willing to sign an informed consent.
* Cooperative, willing to attend all study visits

Exclusion Criteria

* A1c \>= 10.0%
* Two or more documented events of severe hypoglycemia within the previous 12 months
* Diabetes related hospitalization over the past 12 months
* Current significant diabetes-related complications
* Pregnant, lactating or planning to become pregnant during the course of the study
* Substance or alcohol abuse
* Uncontrolled hypertension
* Known dermal hypersensitivity to medical adhesive
* Recurrent episodes of skin infections or dermatological allergies
* Serious or unstable medical or psychological conditions
* Current participation in other clinical studies.
* Working for a competitor company

Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Thomas Pieber, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Schneider Medical Center

Petah Tikva, , Israel

Site Status RECRUITING

Sourasky Medical Center,

Tel Aviv, , Israel

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Andrea Berghofer

Role: CONTACT

Phone: + 43 316 385 80769

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Alona Hamou

Role: primary

Miri MArgaliot